Kornimate/medical-research-clean huggingface dataset:
a non-interventional study to identify the patients with severe luteinizing hormone deficiency in the daily practice

Conditions: Infertility

Summary: this non-interventional study is planned to identify the subjects with severe luteinizing hormone (lh) deficiency in the daily practice. the results will be used for the "periodic safety update report", which is to be regularly sent to the european medicines agency (emea) and the responsible german higher federal authority (bfarm).

female subjects with distinctive follicle stimulating hormone (fsh) and lh deficiency require both fsh and lh. until now these subjects were treated either with a combination of two recombinant preparations (r-hfsh and r-hlh) or else with a menotropin preparation, composed of urinary human fsh (u-hfsh) and human chorionic gonadotropin (hcg) as lh-replacement. in pergoveris™ for the first time both hormones fsh and lh are available as recombinant produced hormones in a combination preparation. pergoveris has both hormones i.e. fsh and lh available as recombinant produced hormones in a combination preparation in the ratio 2:1. this study is planned to record data for the stimulation not only in case of the ovarian stimulation with intercourse for the optimum (vzo) but also the intrauterine insemination (iui) and the ovarian stimulation for the assisted reproduction \[in-vitro fertilisation (ivf) and intracytoplasmatic sperm injection (icsi)\] in subjects with severe fsh and lh deficiency and learn more about this subject group and the applied stimulation plan. apart from the demographic data, anamnestic details e.g. reason for the infertility, duration of the unfulfilled wish for children, past medical treatment for conception and accompanying illnesses will be documented. the duration of the stimulation with pergoveris as well as the dose per day will be recorded from the cycle documentations. follicle sizes and hormones will be documented in accordance with the respectively carried out cycle monitoring. the result of the treatment is related to the number of cycles with ovulation stimulation using hcg, the number of the cycles with puncture, the number of the cycles with embryo transfer, the number and quality of the ova and embryos, on occurred pregnancies and documented abortions. multiple pregnancies and births will also be recorded. objectives * to find the reason for the diagnosis of the severe lh deficiency such as e.g. low endogenous lh, amenorrhea, low endometrial thickness or low estradiol level.

Eligibility criteria:
inclusion criteria: * female subjects undergoing stimulation with pergoveris for the ovarian stimulation with vzo or with iui or in preparation for a technology of the assisted conception such as ivf or icsi exclusion criteria: * subjects receiving combination cycles with clomifen, follitropin beta, urinary fsh, urinary human menopausal gonadotropin (hmg)

Keywords: infertility reproductive technologies, assisted r-hfsh r-hlh pergoveris
mucus solids concentration in patients with bronchiectasis

Conditions: Bronchiectasis

Summary: there is a need for biomarkers that can rapidly and sensitively detect therapeutic benefits of therapies designed to "rehydrate" airways and monitor disease severity and progression. in this study the investigators will evaluate the stability of mucus concentration in patients with bronquiectasis (cf and ncbf) and its ability to respond to acute exacerbations in order to assess whether it can be a good candidate for biomarker.

prospective cross-sectional study of repeated measurements. the recruitment will be performed in 3 different cities of spain: zaragoza, barcelona and murcia. subjects will be asked to repeatedly collect spontaneous and induced sputum samples in both stable and exacerbated conditions. all samples will be collected autonomously by patients in their homes after they have been instructed and supervised. hypertonic saline nebulization will be used for sputum induction.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf (confirmed genetics) or diagnosis of non-cf bronchiectasis through high resolution computed tomography. * aged ≥ 18 years. * clinically stable at the time of recruitment. * chronic sputum production (able to produce spontaneous sputum daily). * current hypertonic saline user. * able to provide written informed consent and perform the trial. exclusion criteria: * current smoker or \>10 pack-year history of tobacco use. * patient in transplantation or retransplantation list.

Keywords: mucus concentration
brain perfusion in pantothenate kinase-associated neurodegeneration (pkan)

Conditions: Pantothenate Kinase-associated Neurodegeneration (PKAN)

Summary: the purpose of this study is to learn whether blood flow in the brain is normal in people with pantothenate kinase-associated neurodegeneration (pkan). specifically, preliminary data suggest a region of the brain called the globus pallidus (gp), a key region affected by pkan, may have reduced blood flow. standard mri and perfusion scanning techniques will be used to learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other brain regions as well as to healthy controls.


Eligibility criteria:
inclusion criteria: * diagnosis of pkan confirmed by mri and gene testing * able to undergo mri for approximately 1 hour without sedation exclusion criteria: * deep brain stimulators or other conditions that warrant avoidance of a strong magnetic field * previous reaction to gadolinium (gd) contrast agent * acute or chronic kidney dysfunction * pregnant and/or nursing at time of study

Keywords: pkan brain iron nbia neurodegeneration with brain iron accumulation hallervorden spatz syndrome
determination of the biological activity of serum from patients

Conditions: Women; Rheumatoid Arthritis

Summary: the main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts). the secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.

the written consent of the subjects will be obtained after full information of the aims, nature and possible risks of the study. before inclusion, subjects will undergo a medical check-up including an interview on personal and family history and drug treatments taken as well as a standard medical examination including weight, height and blood pressure measurement. . their compliance with the inclusion / exclusion criteria will be verified during this review. an interview with personnel involved in the research (a dietician / study research clinic assistant, etc.) will also be carried out as well as a biological selection assessment. as part of this study, the subjects will come a total of 7 times to the emile roux hospital in le puy en velay. the probiotic treatment will begin between 1 and 3 weeks after the inclusion visit. the volunteers / patients recruited will have a volume of blood sampled and a stool collected before the start of the probiotic treatment (t = 0) and at the end of the treatment (t = 4 weeks). the study consists of three periods of probiotic treatment of 4 weeks each interspersed with a wash-out period of 3 weeks in accordance with the recovery period necessary between two blood samples. the sera thus obtained will then be analyzed to determine their biological activity with regard to the induction of changes in the behavior of bone cell models: osteoformin cells (osteoblasts) and osteo-resorbent cells (osteoclasts).

Eligibility criteria:
inclusion criteria: women * 30-75 years * non-menopausal or menopausal for more than 2 years because the tissue osteoarticular is under the influence of steroid hormones. peri-menopause is accompanied by strong hormonal variations. * with rheumatoid arthritis (das28 threshold specified below) * clinical arthritis score ≥ 2.6 (das28). pathology needs to be characterized even if the score remains low * person with good venous condition exclusion criteria: vaccination in the last two months * alcohol abuse with regard to who standards * smoking (\>5 cigarettes/day) -\> 5 hours of intense sport per week * food allergy and others * antibiotic treatment in the month preceding inclusion * persons under guardianship, curators, deprived of liberties, safeguard of justice * refusal to sign the information and consent form

Keywords: rheumatoid arthritis probiotics
prospective evaluation of diagnosis and treatment of patients with autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia

Conditions: Autoimmune Hemolytic Anemia; Immune Thrombocytopenia; Chronic Idiopathic Neutropenia; Autoimmune Neutropenia; Myelodysplastic Syndromes; Cold Agglutinin Disease

Summary: the goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia. the main aims to answer are: * evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome. * evaluation of type and sequence of the therapies administered, the response rates, and the adverse events. * evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome. * evolution of autoimmune cytopenias into myelodysplastic syndromes. * a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism. participants will receive a clinical/laboratory diagnostic workup as per current clinical practice. furthermore they will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.

this observational study will characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia to evaluate predictors of outcome. additionally, a subgroup of patients with myelodysplastic syndromes (diagnosed according to current who 5th edition 2022) will be included to evaluate the presence of autoimmune activation, and red cell metabolism.

Eligibility criteria:
inclusion criteria: * diagnosis of autoimmune cytopenias (aiha/itp/cin/ain) * age \>/= 18 years * ability to sign informed consent * availability to undergo 3 year follow up * for the subgroup of patients with myelodysplastic syndrome: bone marrow evaluation showing \>/= 10% dysplastic features of at least one lineage along with mds defining cytopenia and/or mds defining cytogenetics. exclusion criteria: * any condition impeding the acquisition of the informed consent * immune cytopenia diagnosis preceding \>/= 6 months the enrolment

Keywords: autoimmune hemolytic anemia immune thrombocytopenia chronic idiopathic neutropenia autoimmune neutropenia cold agglutinin disease myelodysplastic syndromes rituximab thrombopoietin receptor agonists erythropoietin steroids splenectomy red cell metabolism cytokines luspatercept microbiome single cell analysis next generation sequencing
a study to test how well different doses of bi 764532 are tolerated by people with a tumour in the brain that is positive for dll3

Conditions: Glioma

Summary: this study (1438-0003) is open to adults with a tumour in the brain that is positive for the tumour marker delta-like 3 (dll3). this study is in people with advanced cancer for whom previous treatment was not successful. the purpose of this study is to find out the highest dose of bi 764532 that people with a brain tumour that is positive for dll3 can tolerate. bi 764532 is an antibody-like molecule that can attach and link together the cancer cells and t-cells of the immune system (dll3/cd3 bispecific). this may help the immune system fight cancer. participants get bi 764532 infusions into a vein when starting treatment. if there is benefit for the participants and if they can tolerate it, the treatment is continued. during this time, participants visit the study site at regular intervals. the total number of visits depends on how they respond to and tolerate the treatment. the first study visits include staying to monitor participants' safety. doctors record any unwanted effects and regularly check the general health of the participants.


Eligibility criteria:
inclusion criteria: 1. male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the first informed consent form (icf1). 2. signed and dated written informed consent (icf1 and icf2) in accordance with international council for harmonisation-good clinical practice (ich-gcp) and local legislation prior to admission to the trial. 3. patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies. 4. availability of archival tumour tissue for delta-like 3 (dll3) expression by central assessment. 5. tumours must be positive for dll3 expression by immunohistochemistry (ihc) on archived tumour tissue according to central pathology review. 6. documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (rano) criteria. 7. karnofsky performance score ≥70. further inclusion criteria apply. exclusion criteria: 1. previous treatment in this trial. 2. current enrolment in another investigational device or drug trial. 3. presence of extracranial metastatic or leptomeningeal disease. 4. previous treatment with therapies targeting dll3. 5. prior treatment with bevacizumab or other anti-vascular endothelial growth factor (anti-vegf) or anti-angiogenic treatment within 6 months prior to first administration of bi 764532. 6. recent anti-cancer therapy: treatment with any other anticancer drug within 21 days or within 5 half-life periods (whichever is shorter) prior to first administration of bi 764532. 7. radiotherapy within the 3 months prior to the diagnosis of progression; unless tumour progression is clearly outside the radiation field or tumour progression is unequivocally proven by surgery/biopsy. further exclusion criteria apply.
efficacy and safety of enn0403 in patients at high risk for acute kidney injury following elective cardiac surgery

Conditions: Cardiac Surgery Associated - Acute Kidney Injury

Summary: the is a two-stage study. stage 1 is to evaluate the safety, tolerability, pk and pd of enn0403 in patients at high risk of aki following elective cardiac surgery requring cardiopulmonary bypass. stage 2 is to evaluate the efficacy, safety, pk and pd of enn0403 to prevent and treat aki after multiple administraions in patients at high risk of aki following elective cardiac surgery requring cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: 1. ability to understand and comply with the study requirements and able to provide written informed consent; 2. age ≥18 and ≤85 years; 3. male subjects (and their fertile female spouses/partners) do not have pregnancy plans during the screening period and within 3 months after the last dose, voluntarily take highly effective contraception, and must not donate sperm or ova. only non-fertile women will be enrolled, and female subjects who meet the following criteria are not considered fertile: postmenopausal status has been achieved, normal menstruation has stopped for at least 12 consecutive months with an fsh \>30 iu/l in the absence of other pathophysiological causes, or there is a medical record showing hysterectomy \\ bilateral tubal resection and/or bilateral ovariectomy. 4. subjects must be scheduled for cardiac surgery requring cardiopulmonary bypass: coronary artery bypass grafting (cabg) and/or heart valve surgery and/or aortic root, ascending aorta and aortic arch surgery; 5. subjects have the risk of developing aki with at least one of the following criteria: coronary artery bypass grafting combined with one or more heart valves surgery plus at least one risk factor for aki; multiple heart valves surgery plus at least one aki risk factor; coronary artery bypass grafting or aortic valve surgery combined with aortic root, ascending aorta, and aortic arch surgery (non-aortic dissection) plus at least one risk factor for aki; coronary artery bypass grafting alone or single heart valve surgery plus at least 2 risk factors for aki. exclusion criteria: 1. receive icd or permanent pacemaker implantation, mechanical ventilation, iabp, lvad or other mechanical circulatory aids within 1 week before surgery; 2. cardiopulmonary resuscitation is performed within 14 days prior to screening; 3. abnormal renal function with egfr\<20 ml/min/1.73 m2 within 30 days before screening; 4. receive renal replacement therapy or the presence of aki within 30 days before surgery, except for transient (≤5 days) stage 1 aki after iodized contrast agent exposure; 5. participate in other clinical trials within the past 1 month; 6. have a known allergy to investigational drug or any of its constituents, or allery to any constituents used during the study; 7. subjects with intractable hypotension, severe hypoxemia or other emergency during surgery.
effect of renal impairment on enpatoran pharmacokinetics

Conditions: Renal Impairment

Summary: the purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.


Eligibility criteria:
inclusion criteria: for control group 1 (normal renal function): * medical history and physical examination without any ongoing clinically relevant findings as judged by the investigator * no clinically relevant findings (only minor deviations) in biochemistry, hematology, coagulation, and urinalysis examinations for the age of the participant, as judged by the investigator; absolute lymphocyte count and absolute neutrophil count must be within normal limits for group 2 (impaired renal function): * medical history and physical examination without any ongoing clinically relevant findings except for the underlying disease leading to renal impairment and consequence diseases thereof * chronic kidney disease * for participants under medication, stable medication for at least 1 month * other protocol defined inclusion criteria could apply exclusion criteria: * history or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such as ventricular dysfunction and congestive heart failure, cardiac arrythmia), psychiatric, neurological, genitourinary, immunological, dermatological, connective tissue diseases, or disorders that may affect the safety of the participant. * history of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the investigator's discretion * history or presence of epilepsy, neurological disorders with seizure propensity or undiagnosed loss of consciousness, severe head trauma within 6 months or severe depression within 12 months prior to screening), or neuropsychiatric conditions * history of serotonin syndrome * prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to screening, which might interfere with the objectives of the study or the study procedures * other protocol defined exclusion criteria could apply

Keywords: renal impairment clinical pharmacology pharmacokinetics
sitagliptin in the elderly

Conditions: Type 2 Diabetes

Summary: diabetes is common in the elderly; by the age of 70, approximately 25% of the population will have diabetes. unfortunately, currently available medications are often not as effective or not well tolerated in older adults. sitagliptin is a new medication in a new class of agent called incretins. incretins have many potential advantages for the treatment of diabetes in the elderly. they stimulate insulin secretion, which is impaired in all older people with diabetes. the incidence of hypoglycemia with currently available medications increases with age, and incretins rarely cause hypoglycemia . they assist with weight loss, whereas many current medications used to manage diabetes result in weight gain in the elderly. they improve insulin action, and insulin resistance is a major problem in older people with diabetes.

to date, no clinical trials have been conducted specifically in the elderly, but the data noted above from our laboratory would imply that inhibitors of this enzyme could be more effective in the elderly patient population. in addition, we have convincingly demonstrated that diabetes in the elderly is metabolically distinct from diabetes in middle aged patients (1). thus, it is clear further studies are warranted to determine the effectiveness of drugs in this class in elderly patients with diabetes. we propose a series of studies with your dp4 inhibitor sitaglipitin to determine its efficacy and safety in an elderly patient population with diabetes.

Eligibility criteria:
inclusion criteria: * type 2 diabetes managed by diet or metformin only * a1c \< 8.5% exclusion criteria: * treated with insulin or oral agents other than metformin in the past 6 months * evidence of diabetic complications including coronary artery disease, stroke, transient ischemic attacks, peripheral vascular disease, nephropathy, retinopathy, or neuropathy * type 1 diabetes or a history suggestive of a secondary causes of diabetes * a1c ≥ 8.5% * participated in another clinical trial within the past 30 days

Keywords: type 2 diabetes older adults incretins hyperglycemia insulin resistance